Peristomal Mesh for Prophylaxis of Parastomal Hernia

Oslo University Hospital60 enrolled

Overview

The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.

Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation. Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hernia

Interventions

Mesh in permanent colostomyDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Condition with indication for establishing a permanent end-colostomy. Exclusion Criteria: * Age under 18 * ASA score above 3

Locations (1)

Rikshospitalet-Radiumhospitalet HF

Oslo, Norway

Outcomes

Primary Outcomes

Parastomal hernia

Time frame: at 3, 12, 24, 36 and 48 months

Secondary Outcomes

Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy

Time frame: 4 years

Data from ClinicalTrials.gov

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